FDA recalls two rapid COVID-19 tests, citing false results

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FDA recalls two rapid COVID-19 tests, citing false results

The FDA has urged people to stop using the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

The Food and Drug Administration has recalled two rapid COVID-19 tests and urged people to stop using them.

On Friday, the FDA issued a warning against using the ​CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test from Empowered Diagnostics.

According to the recall notice, the tests were distributed between January and November of last year. At least 284,575 of the antigen tests and 2,100 of the antibody tests were distributed.

The tests falsely advertised themselves as being authorized by the FDA despite having no actual authorization or clearance. Both tests have a risk of false negative and false positive results, according to the FDA.

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab to detect the virus that causes COVID-19, while the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a blood sample to detect antibodies created by the body’s immune response.

Both Empowered Diagnostics and the FDA have issued a recall for the tests. The FDA has also recommended health care providers retest patients using an authorized test if they suspect infection. 

Read the full article on bringmethenews.com.

Read the FDA recall notice on fda.gov.

OlleyMay Safety has an inventory of FDA-authorized COVID-19 rapid test kits.  To order, call
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